To study the severity of abdominal pain and shoulder tip pain in low versus standard pressure pneumoperitoneum during laparoscopic cholecystectomy.

Completed

Conditions: Calculus of gallbladder without cholecystitis,

Registration Number: CTRI/2019/02/017490

Lead Sponsor: ARMED FORCES MEDICAL COLLEGE

Brief Summary: Biliary diseases known since ages constitute a major portion of digestive tract disorders world over and Gallstone disease is a major cause of abdominal morbidity and mortality.1 Almost 10% of the population has gallstones, and cholecystectomy is the most common surgical method to treat it in the Western countries.2 However, today, the laparoscopic cholecystectomy (LC) is the gold standard to treat gallstones and has replaced the open cholecystectomy that now remains a choice only in some complicated cases.

Laparoscopy cholecystectomy was first introduced by Dubois in 1988 and gradually developed by monitor and video systems.3,4 But for clear visualisation of surgical site during LC; pneumoperitoneum has to be created.5 In modern minimal access surgery worldwide, Carbon dioxide is the commonest means of achieving pneumoperitoneum and it is the same gas responsible for postoperative shoulder tip pain whose reported incidence is 30 to 50% in patients following laparoscopic cholecystectomy.6 It is now well documented that physiologic changes in cardiovascular system, respiratory system, and blood chemistry occur during creation of pneumoperitoneum. These changes usually are associated with either increased intra-abdominal pressure or with use of CO2.7

The adverse events reported with pneumoperitoneum include decreased pulmonary compliance, altered blood gas parameters, impaired functioning of the circulatory system, raised liver enzymes and renal dysfunction and increased intra-abdominal venous pressures. The duration of convalescence after uncomplicated laparoscopic cholecystectomy depend on several factors of which shoulder tip pain is more important. Other are nausea, vomiting, ileus, postoperative fatigue, postoperative hospital stays, recovery time.8 The current trend is to employ low pressure laparoscopic cholecystectomy (LPLC). While standard pressure pneumoperitoneum, employs a pressure range of 12-14 mm Hg, the low pressure pneumoperitoneum ranges from 7-10 mm Hg. Low pressure technique was attempted to

lower the impact of pneumoperitoneum like CO2 embolism, vaso-vagal reflex, cardiac arrhythmia, hypercarbic acidosis and minimizes haemodynamic effect of insufflation.

However, most important drawback of applying low pressure is the inadequate exposure of the operating space that can result in longer than usual operating time, higher rate of intraoperative complications and also possibly higher frequency of conversion to standard pressure laparoscopic cholecystectomy (SPLC) or open cholecystectomy.1

Several studies have compared the effects of reduced pressure (7-9 mm Hg) with standard pressure (12-15 mm Hg) during LC. These studies illustrate the feasibility of low pressure PP, along with some advantages in terms of postoperative pain.9

Thus, the present study was designed to study the level of abdominal pain and shoulder tip

pain post surgery in two groups of patients undergoing LPLC and SPLC

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 84

Inclusion Criteria

ALL PATIENT UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY.

Exclusion Criteria

i.Rupture of gallbladder, ii.
Empyema, iii.
Common bile duct stones, iv.
Patients undergoing extensive upper abdominal surgery, v.
Pregnant females, patients with body mass index (BMI) >30 and <19, vi.
Fatty liver grade 3 and 4, vii.
Elevated liver enzymes before the surgery.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To study the hemodynamic changes in standard versus low pressure LC patients.	1,3,6,12,24 hours post surgery
2.To study the level of abdominal pain in standard versus low pressure LC patients.	1,3,6,12,24 hours post surgery

Secondary Outcome Measures

Name	Time	Method
1.To study the risk factor and complication involved in the two group of patients.	2.To study the changes in liver enzymes among the two groups of patients.

Trial Locations

Locations (1): ARMED FORCES MEDICAL COLLEGE
🇮🇳
Pune, MAHARASHTRA, India
ARMED FORCES MEDICAL COLLEGE
🇮🇳Pune, MAHARASHTRA, India
BRIG DR SITARAM GHOSH
Principal investigator
8551047907
sitaram.ghosh@rediffmail.com